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Etanercept (Enbrel) Special Investigation (Regulatory Post Marketing Commitment Plan)

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ClinicalTrials.gov Identifier: NCT01230177
Recruitment Status : Completed
First Posted : October 28, 2010
Results First Posted : February 23, 2017
Last Update Posted : February 23, 2017
Sponsor:
Information provided by (Responsible Party):
Pfizer

Study Type Observational
Study Design Observational Model: Case-Only;   Time Perspective: Prospective
Conditions Arthritis
Rheumatoid
Intervention Drug: etanercept (genetical recombination)
Enrollment 3
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Etanercept(Genetial Recombination)
Hide Arm/Group Description Participants in whom the regimen of etanercept was changed from 10 mg twice weekly to 25 mg once weekly for the treatment of rheumatoid arthritis.
Period Title: Overall Study
Started 3
Completed 3
Not Completed 0
Arm/Group Title Etanercept (Renetical Recombination)
Hide Arm/Group Description Participants in whom the regimen of etanercept was changed from 10 mg twice weekly to 25 mg once weekly for the treatment of rheumatoid arthritis.
Overall Number of Baseline Participants 3
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 3 participants
<65 years 0
>=65 years 3
Gender  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants
Female
3
 100.0%
Male
0
   0.0%
1.Primary Outcome
Title Number of Participants With Treatment Related Adverse Events
Hide Description Adverse events are defined as any unfavorable events, including clinically significant abnormal changes in laboratory test values, which develop in participants after the administration of etanercept regardless of the causal relationship to etanercept. The causal relationship between an adverse event and etanercept was evaluated by the sponsor.
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The safety analysis population consisted of the participants in whom the regimen of etanercept was changed from 10 mg twice weekly to 25 mg once weekly for the treatment of rheumatoid arthritis.
Arm/Group Title Etanercept(Genetial Recombination)
Hide Arm/Group Description:
Participants in whom the regimen of etanercept was changed from 10 mg twice weekly to 25 mg once weekly for the treatment of rheumatoid arthritis.
Overall Number of Participants Analyzed 3
Measure Type: Number
Unit of Measure: participants
2
2.Primary Outcome
Title Disease Activity Score of 28 Joints (DAS28: 4/Erythrocyte Sedimentation Rate [ESR])
Hide Description

DAS28-4 (ESR) was calculated from SJC and TJC using 28 joints count, ESR (mm/hour) and PtGA of disease activity (participant rated arthritis activity assessment). Total score range: 0-9.4, higher score=more disease activity. DAS28-4 (ESR) <= 3.2 implied low disease activity and >3.2 to 5.1 implied moderate to high disease activity, and DAS28-4 (ESR) <2.6 = remission.

DAS28-3 (ESR) was calculated from SJC and TJC using 28 joints count, ESR (mm/hour). Total score range: 0-9.4, higher score=more disease activity. DAS28-3 (ESR) <= 3.2 implied low disease activity and >3.2 to 5.1 implied moderate to high disease activity, and DAS28-3 (ESR) <2.6 = remission.

Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Etanercept(Genetial Recombination)
Hide Arm/Group Description:
Participants in whom the regimen of etanercept was changed from 10 mg twice weekly to 25 mg once weekly for the treatment of rheumatoid arthritis.
Overall Number of Participants Analyzed 1
Mean (Standard Deviation)
Unit of Measure: Score
At 0 week 3.55  (0)
At 8 weeks 2.72  (0)
3.Primary Outcome
Title Change in Disease Activity Score of 28 Joints (DAS28: 4/Erythrocyte Sedimentation Rate [ESR])
Hide Description

DAS28-4 (ESR) was calculated from SJC and TJC using 28 joints count, ESR (mm/hour) and PtGA of disease activity (participant rated arthritis activity assessment). Total score range: 0-9.4, higher score=more disease activity. DAS28-4 (ESR) <= 3.2 implied low disease activity and >3.2 to 5.1 implied moderate to high disease activity, and DAS28-4 (ESR) <2.6 = remission.

DAS28-3 (ESR) was calculated from SJC and TJC using 28 joints count, ESR (mm/hour). Total score range: 0-9.4, higher score=more disease activity. DAS28-3 (ESR) <= 3.2 implied low disease activity and >3.2 to 5.1 implied moderate to high disease activity, and DAS28-3 (ESR) <2.6 = remission.

Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Etanercept(Genetial Recombination)
Hide Arm/Group Description:
Participants in whom the regimen of etanercept was changed from 10 mg twice weekly to 25 mg once weekly for the treatment of rheumatoid arthritis.
Overall Number of Participants Analyzed 1
Mean (Standard Deviation)
Unit of Measure: percent change
At 0 week 0  (0)
At 8 weeks -23.58  (0)
4.Secondary Outcome
Title Physician's Assessment of Clinical Effect of Etanercept on the Symptoms of Rheumatoid Arthritis and Change in Laboratory Values
Hide Description On the basis of how well the clinical symptoms of rheumatoid arthritis were controlled at baseline, the physician assessed the clinical effect of etanercept in two grades: "effective" or "ineffective". To assess the clinical efficacy of etanercept, the degrees of the symptoms of rheumatoid arthritis and laboratory test values were compared between at baseline and at the 12th week of the investigation.
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The efficacy analysis population consisted of the participants in whom the change in DAS28 (4/ESR and 3/ESR) was calculated. No descriptive statistic on the change in DAS28 (4/ESR and 3/ESR) was calculated due to a very small number of participants (n = 3).
Arm/Group Title Etanercept(Genetial Recombination)
Hide Arm/Group Description:
Participants in whom the regimen of etanercept was changed from 10 mg twice weekly to 25 mg once weekly for the treatment of rheumatoid arthritis.
Overall Number of Participants Analyzed 3
Measure Type: Number
Unit of Measure: participants
Effective 3
Ineffective 0
5.Secondary Outcome
Title Physician's Assessment of Clinical Effect of Etanercept on the Symptoms of Rheumatoid Arthritis and Change in Laboratory Values
Hide Description On the basis of how well the clinical symptoms of rheumatoid arthritis were controlled at baseline, the physician assessed the clinical effect of etanercept in two grades: "effective" or "ineffective". To assess the clinical efficacy of etanercept, the degrees of the symptoms of rheumatoid arthritis and laboratory test values were compared between at baseline and at the 12th week of the investigation.
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The efficacy analysis population consisted of the participants in whom the change in DAS28 (4/ESR and 3/ESR) was calculated. No descriptive statistic on the change in DAS28 (4/ESR and 3/ESR) was calculated due to a very small number of participants (n = 3).
Arm/Group Title Etanercept(Genetial Recombination)
Hide Arm/Group Description:
Participants in whom the regimen of etanercept was changed from 10 mg twice weekly to 25 mg once weekly for the treatment of rheumatoid arthritis.
Overall Number of Participants Analyzed 3
Measure Type: Number
Unit of Measure: participants
Effective 3
Ineffective 0
Time Frame [Not Specified]
Adverse Event Reporting Description The frequency of treatment related adverse events during the study
 
Arm/Group Title Etanercept(Genetial Recombination)
Hide Arm/Group Description Participants in whom the regimen of etanercept was changed from 10 mg twice weekly to 25 mg once weekly for the treatment of rheumatoid arthritis.
All-Cause Mortality
Etanercept(Genetial Recombination)
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Etanercept(Genetial Recombination)
Affected / at Risk (%) # Events
Total   1/3 (33.33%)    
Infections and infestations   
Pneumonia  1  1/3 (33.33%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA-J 15.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Etanercept(Genetial Recombination)
Affected / at Risk (%) # Events
Total   2/3 (66.67%)    
Eye disorders   
Keratitis  1  1/3 (33.33%)  1
General disorders   
Injection site reaction  1  1/3 (33.33%)  1
Infections and infestations   
Nasopharyngitis  1  2/3 (66.67%)  2
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA-J 15.0
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
Phone: 1-800-718-1021
EMail: ClinicalTrials.gov_Inquiries@pfizer.com
Layout table for additonal information
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01230177     History of Changes
Other Study ID Numbers: B1801134
First Submitted: October 27, 2010
First Posted: October 28, 2010
Results First Submitted: March 27, 2014
Results First Posted: February 23, 2017
Last Update Posted: February 23, 2017